NCT02050074已完成4 期
The Role of Metformin and Colesevelam in Human GLP-1 Secretion
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in the gut hormone glucagon-like peptide 1 (GLP-1)
研究概览
简要总结
Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal hemoglobin
- •BMI > 23kg/m2
- •HbA1c <9 %
- •Informed concent
排除标准
- •Liver disease ( aspartate aminotransferase/alanine aminotransferase >2 × reference value)
- •Chronic intestinal disease
- •History of liver and / or gallbladder disease
- •Nephropathy (se-creatinine >110 µM and / or albuminuria)
- •Insulin or GLP-1-based antidiabetic treatment
- •History of cholecystectomy or surgical resection of bowel segment
- •BMI <23kg/m2 or BMI >35 kg/m2
- •Pregnancy
研究组 & 干预措施
Metformin + exendin (9-39)
Experimental
干预措施: Metformin (Drug)
Colesevelam + exendin (9-39)
Experimental
干预措施: Colesevelam (Drug)
Colesevelam
Experimental
干预措施: Colesevelam (Drug)
Metformin
Experimental
干预措施: Metformin (Drug)
Placebo
Experimental
干预措施: Placebo (Other)
Placebo + + exendin (9-39)
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Change in the gut hormone glucagon-like peptide 1 (GLP-1)
时间窗: 0-240 min
次要结局
未报告次要终点
研究者
Morten Hansen
Dr.
University Hospital, Gentofte, Copenhagen
研究点 (1)
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